Phase 1 Liver Cancer Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 18 to 70 years, of any gender
• People who have voluntarily agreed to take part and signed a consent form (either themselves or through a guardian)
• People with liver cancer (HCC) that cannot be surgically removed, classified as stage B or C under a system called BCLC staging — if stage B, the cancer must have progressed after surgery or local treatment, or surgery/local treatment must not be suitable
• People who have already received at least one systemic treatment (such as targeted therapy, immunotherapy, or chemotherapy) and whose cancer has continued to grow or spread during or after that treatment
• People with a liver disease severity score (Child-Pugh score) of 7 or below
• People who have had imaging scans within the past 28 days showing at least one measurable tumour in the liver that can be reliably tracked over time
• People whose doctors estimate they are likely to live for more than 12 weeks
• People whose tumour tissue tests positive for a protein called GPC3, confirmed by a laboratory test on a tissue sample
• People with a physical performance score (ECOG) of 0 or 1, meaning they are fully active or able to carry out light activity
• People with adequate organ function as assessed by the trial team
• People who test negative for the hepatitis B surface antigen (HBsAg), or — if certain hepatitis B markers are positive — whose hepatitis B virus levels in the blood are below a specific threshold
• Women of childbearing age who test negative for pregnancy within 7 days before the cell therapy and who are not breastfeeding; all participants of childbearing age are required to use effective contraception throughout the study and for up to one year after the CAR-T cell treatment

Who may not be able to join:

• People whose liver tumours could be fully removed by surgery, or who are considered suitable candidates for a liver transplant
• Women who are pregnant or breastfeeding
• People who have had an active bacterial or fungal infection in the 72 hours before a procedure called apheresis (a blood cell collection process), unless they have no signs of active infection and are only taking preventive medications
• People who have taken steroid medications at a dose equivalent to more than 15 mg per day of prednisone within the 2 weeks before apheresis (except for inhaled steroids)
• People whose blood counts fall below certain levels before apheresis — specifically, haemoglobin below 80 g/L, white blood cell count (ANC) below 1.0 × 10⁹/L, or platelet count below 60 × 10⁹/L
• People with significant fluid build-up in the abdomen (ascites) that is detectable on physical examination or requires treatment such as drainage or medication
• People whose imaging shows that tumour has replaced 50% or more of the liver, or where the cancer has spread into major blood vessels near the liver or bowel
• People who have ever had, or currently have, a condition called hepatic encephalopathy (brain problems caused by liver disease)
• People with active cancer that has spread to the brain
• People who have previously had an organ transplant or are currently waiting for one, including a liver transplant
• People with certain active viral infections, including hepatitis B with high virus levels in the blood, active hepatitis C, HIV, or syphilis
• People with other serious medical conditions that the trial team considers would prevent safe participation
• People who received anti-cancer treatment within 2 weeks before apheresis, or any experimental drug or systemic anti-cancer treatment within 28 days (or within 5 half-lives of the drug, whichever applies) before signing the consent form
• People who have previously received any treatment specifically targeting the GPC3 protein
• People who still have side effects from previous PD-1 or PD-L1 immunotherapy that have not returned to mild (grade 1) or baseline levels at the time of signing consent — except for hair loss or skin colour changes
• People who have had another cancer (other than early-stage cervical cancer or a type of skin cancer called basal cell carcinoma) within the past 5 years or at the same time as their current diagnosis
• People who, in the trial team's judgement, are unable or unwilling to follow the requirements of the study

Important: Always verify eligibility with the trial site directly before applying.